2010 No. 801 ANIMALS, ENGLAND. The Transmissible Spongiform Encephalopathies (England) Regulations 2010

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1 STATUTORY INSTRUMENTS 2010 No. 801 ANIMALS, ENGLAND ANIMAL HEALTH The Transmissible Spongiform Encephalopathies (England) Regulations 2010 Made th March 2010 Laid before Parliament 16th March 2010 Coming into force - - 6th April 2010 CONTENTS PART 1 General Provisions 1. Title, application and commencement 3 2. Interpretation 3 3. Appointment of competent authority 5 4. Exception for research 5 PART 2 Introduction of Schedules 5. The Schedules 6 PART 3 Administration and Enforcement 6. Approvals, authorisations, licences or registrations 6 7. Occupier s duty 6 8. Suspension and amendment 7 9. Revocations of approvals, authorisations, licences or registrations Appeals Valuations Appointment of inspectors Powers of entry Powers of inspectors Notices Notices restricting movement 10

2 17. Obstruction Penalties Corporate offences Enforcement Amendment of the Animal By-Products (Identification) Regulations Consequential amendment Revocations 12 SCHEDULES SCHEDULE 1 Ambulatory References 13 SCHEDULE 2 TSE Monitoring 13 PART 1 Monitoring for TSE 14 PART 2 Contents of an RMOP 19 SCHEDULE 3 Control and eradication of TSE in bovine animals 20 SCHEDULE 4 Control and eradication of TSE in sheep and goats 24 SCHEDULE 5 Control and eradication of TSE in animals that are not bovine, ovine or caprine 31 SCHEDULE 6 Feedingstuffs 33 PART 1 Restrictions on feeding proteins to animals 33 PART 2 Production of protein and feedingstuffs 36 SCHEDULE 7 Specified risk material, mechanically separated meat and slaughtering techniques 42 SCHEDULE 8 Restrictions on placing on the market and export 46 The Secretary of State has been designated(a) for the purposes of section 2(2) of the European Communities Act 1972(b) in relation to measures in the veterinary and phytosanitary fields for the protection of public health. The Secretary of State makes the following Regulations under the powers conferred by section 2(2) of, and paragraph 1A of Schedule 2 to, the European Communities Act 1972 and by section 56(1) and (2) of the Finance Act 1973(c). The Secretary of State has carried out the consultation required by Article 9 of Regulation (EC) No 178/2002(d) of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. These Regulations make provision for a purpose mentioned in section 2(2) of the European Communities Act 1972 and it appears to the Secretary of State that it is expedient for references to the EU instruments referred to in Schedule 1 to be construed as references to those instruments as amended from time to time. (a) S.I. 1999/2027. (b) 1972 c.68. Paragraph 1A of Schedule 2 was inserted by section 28 of the Legislative and Regulatory Reform Act 2006 (c. 51). (c) 1973 c. 51. (d) OJ No L 31, , p 1, as last amended by Regulation (EC) No 1642/2003 (OJ No L 245, , p 4). 2

3 In accordance with section 56(1) of the Finance Act 1973, the Treasury consents to the making of these Regulations. Title, application and commencement PART 1 General Provisions 1. These Regulations (a) may be cited as the Transmissible Spongiform Encephalopathies (England) Regulations 2010; (b) apply in England; and (c) come into force on 6th April Interpretation 2. (1) In these Regulations approved sampling site has the meaning given to it in paragraph 11(2) of Schedule 2; approved testing laboratory has the meaning given to it in paragraph 10(3) of Schedule 2; bovine animal includes bison and buffalo (including water buffalo); BSE means bovine spongiform encephalopathy; cattle passport has the same meaning as in the Cattle Identification Regulations 2007(a); Commission Decision 2007/411/EC means Commission Decision 2007/411/EC(b) prohibiting the placing on the market of products derived from bovine animals born or reared within the United Kingdom before 1st August 1996 for any purpose and exempting such animals from certain control and eradication measures laid down in Regulation (EC) No 999/2001 and repealing Decision 2005/598; cutting plant (except in Schedule 7, paragraph 9(3)(b)(iii)) has the meaning given to it in paragraph 1(17) of Annex I to Regulation (EC) No 853/2004(c), and is an establishment that is approved or conditionally approved as such by the Food Standards Agency(d) under Article 31(2) of Regulation (EC) No 882/2004(e), or operating as such under Article 4(5) of Regulation (EC) No 853/2004, pending such approval; EU TSE Regulation means Regulation (EC) No 999/2001(f) of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies, as read with (a) Commission Decision 2007/411/EC; and (a) S.I. 2007/529. (b) OJ No L 155, , p 74. (c) OJ No L 139, , p 55. The revised text of Regulation (EC) No 853/2004 is now set out in a Corrigendum (OJ No L 226, , p 22), which should be read with a further Corrigendum (OJ No L 204, , p 26), as last amended by Commission Regulation (EC) No 1020/2008 amending Annexes II and III to Regulation (EC) No 853/2004 of the European Parliament and the Council laying down specific hygiene rules for food of animal origin and Regulation (EC) No 2076/2005 as regards identification marking, raw milk and dairy products, eggs and egg products and certain fishery products (OJ No L 277, , p 8). (d) Established by the Food Standards Act 1999 c. 28. (e) OJ No L 165, , p 1. The revised text of Regulation (EC) No 882/2004 is now set out in a Corrigendum (OJ No L 191, , p 1), which should be read with a further Corrigendum (OJ No L 204, , p 29). Regulation (EC) No 882/2004 was last amended by Commission Regulation (EC) No 1029/2008 amending Regulation (EC) No 882/2004 of the European Parliament and of the Council to update a reference to certain European standards (OJ No. L 278, , p 6). (f) OJ No L 147, , p 1, as last amended by Commission Regulation (EC) No 571/2008 (OJ No L 161, , p 4). 3

4 (b) Commission Decision 2007/453/EC(a) establishing the BSE status of Member States or third countries or regions thereof according to their BSE risk; (c) Commission Decision 2009/719/EC(b) authorising certain Member States to revise their annual BSE monitoring programme; inspector means an inspector appointed under regulation 12, and veterinary inspector means a veterinary surgeon appointed by the Secretary of State as an inspector; local authority means (a) where there is, within the meaning of the Local Government Changes for England Regulations 1994(c), a unitary authority, that authority; (b) where there is not a unitary authority (i) in a metropolitan district, the council of that district; (ii) in a non-metropolitan county, the council of that county or the council of a district within the county area; (iii) in each London borough, the council of that borough; or (c) in the City of London, the Common Council; offal has the meaning given to it in point 1.11 of Annex I to Regulation (EC) No. 853/2004; premises includes (a) domestic premises if they are being used for any purpose in connection with the EU TSE Regulation or these Regulations; (b) land and outbuildings; (c) a slaughterhouse; (d) a place that is, for the purposes of point 4(1)(a) of Annex V to the EU TSE Regulation, another place of slaughter; and (e) any vehicle, container or structure (moveable or otherwise); Regulation (EC) No 1774/2002 means Regulation (EC) No 1774/2002(d) of the European Parliament and of the Council laying down health rules concerning animal by-products not intended for human consumption, as read with (a) Commission Regulation (EC) No 811/2003(e) implementing Regulation (EC) No 1774/2002 of the European Parliament and of the Council as regards the intraspecies recycling ban for fish, the burial and burning of animal by-products and certain transitional measures; (b) Commission Regulation (EC) No 878/2004(f) laying down transitional measures in accordance with Regulation (EC) No 1774/2002 for certain animal by-products classified as Category 1 and 2 materials and intended for technical purposes; and (c) Commission Regulation (EC) No 92/2005(g) implementing Regulation (EC) No 1774/2002 of the European Parliament and of the Council as regards means of disposal or uses of animal by-products and amending its Annex VI as regards biogas transformation and processing of rendered fats; Regulation (EC) No 853/2004 means the Regulation of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin, as read with (a) OJ No L 172, , p 84 as last amended by Commission Decision 2009/830/EC (OJ No L 295, , p 11). (b) OJ No L 256, , p 35, as last amended by Commission Decision 2010/66/EU (OJ NoL 35, , p 21). (c) S.I. 1994/867 to which there are amendments not relevant to these Regulations. (d) OJ No L 273, , p 1, as last amended by Commission Regulation (EC) No 523/2008 (OJ No L 153, , p 23). Commission Regulation (EC) No 1069/2009 (OJ No L 300, p. 1) will repeal and replace Regulation (No) 1774/2002 on 4 March (e) OJ No L 117, , p 14. (f) OJ No L 162, , p 62, as amended by Regulation (EC) No 1877/2006 (OJ No L 360, , p 133). (g) OJ No L 19, , p 27, as last amended by Regulation (EC) No 1576/2007 (OJ No L 340, , p 89). 4

5 (a) Directive 2004/41/EC(a) of the European Parliament and of the Council repealing certain directives concerning food hygiene and health conditions for the production and placing on the market of certain products of animal origin intended for human consumption and amending Council Directives 89/662/EEC and 92/118/EEC and Council Decision 95/408/EC; (b) Commission Regulation (EC) No 1688/2005(b) implementing Regulation (EC) No 853/2004 of the European Parliament and of the Council as regards special guarantees concerning salmonella for consignments to Finland and Sweden of certain meat and eggs; (c) Commission Regulation (EC) No 2074/2005(c) laying down implementation measures for certain products under Regulation (EC) No 853/2004 of the European Parliament and of the Council and for the organisation of official controls under Regulation (EC) No 854/2004 of the European Parliament and of the Council and Regulation (EC) No 882/2004 of the European Parliament and of the Council derogating from Regulation (EC) No 852/2004(d) of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/2004; and (d) Commission Regulation (EC) No 2076/2005(e) laying down transitional arrangements for the implementation of Regulations (EC) No 853/2004, (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/2004; Regulation (EC) No 882/2004 means the Regulation of the European Parliament and of the Council on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules, as read with (a) Commission Regulation (EC) No 2074/2005; and (b) Commission Regulation (EC) No 2076/2005; slaughterhouse has the meaning given to it in paragraph 1(16) of Annex I to Regulation (EC) No 853/2004, and is an establishment that is approved or conditionally approved as such by the Food Standards Agency under Article 31(2) of Regulation (EC) No 882/2004; TSE means transmissible spongiform encephalopathy. (2) Expressions that are not defined in these Regulations and occur in the EU TSE Regulation have the same meaning in these Regulations as they have for the purposes of the EU TSE Regulation. (3) References in these Regulations to the EU instruments identified in Schedule 1 are references to those instruments as amended from time to time. Appointment of competent authority 3. The Secretary of State is the competent authority for the purposes of the EU TSE Regulation except as otherwise specified in these Regulations. Exception for research 4. (1) The provisions of Schedules 2 to 8 do not apply in relation to animals kept for the purposes of research in premises approved for that purpose under this regulation by the Secretary of State. (a) OJ No L 157, , p 33. The revised text of Directive 2004/41/EC is now set out in a Corrigendum (OJ No L 195, , p 12). (b) OJ No L 271, , p 17. (c) OJ No L 338, , p 27, as last amended by Commission Regulation (EC) No 1022/2008 amending Regulation (EC) No 2074/2005 as regards the total volatile basic nitrogen (TVB-N) limits (OJ No L 277, , p 18). (d) OJ No L p 1). (e) OJ No L 338, , p 83, as last amended by Commission Regulation (EC) No 1023/2008 amending Regulation (EC) No 2076/2005 as regards the extension of the transitional period granted to food business operators importing fish oil for human consumption (OJ No L 277, , p 21). 5

6 (2) If a bovine animal, sheep or goat kept in approved research premises or its progeny dies or is killed, the occupier must dispose of it as a Category 1 animal by-product in accordance with Regulation (EC) No 1774/2002, and failure to do so is an offence. The Schedules PART 2 Introduction of Schedules 5. The following Schedules have effect (a) Schedule 2 (TSE monitoring); (b) Schedule 3 (control and eradication of TSE in bovine animals); (c) Schedule 4 (control and eradication of TSE in sheep and goats); (d) Schedule 5 (control and eradication of TSE in animals that are not bovine, ovine or caprine); (e) Schedule 6 (feedingstuffs); (f) Schedule 7 (specified risk material, mechanically separated meat and slaughtering techniques); and (g) Schedule 8 (restrictions on placing on the market and export). PART 3 Administration and Enforcement Approvals, authorisations, licences or registrations 6. (1) The Secretary of State must grant an approval, authorisation, licence or registration under these Regulations if the Secretary of State is satisfied that the provisions of the EU TSE Regulation and these Regulations will be complied with. (2) It must be in writing, and must specify (a) the address of the premises; (b) the name of the occupier; and (c) the purpose for which it is granted. (3) It may be made subject to such conditions as are necessary to (a) ensure that the provisions of the EU TSE Regulation and these Regulations will be complied with; or (b) protect public or animal health. (4) Where refusing to grant an approval, authorisation, licence or registration, or granting one subject to conditions, the Secretary of State must (a) give reasons in writing; and (b) explain that the applicant has the right to make written representations to a person appointed by the Secretary of State. (5) The appeals procedure in regulation 10 then applies. Occupier s duty 7. The occupier of any premises approved, authorised, licensed or registered under these Regulations commits an offence if they do not ensure that 6

7 (a) the premises are maintained and operated in accordance with (i) any condition of the approval, authorisation, licence or registration; (ii) the requirements of the EU TSE Regulation and these Regulations; and (b) any person employed by them, and any person permitted to enter the premises, complies with those conditions and requirements. Suspension and amendment 8. (1) The Secretary of State may suspend or amend an approval, authorisation, licence or registration granted under these Regulations if (a) any of the conditions under which it was granted is not fulfilled; or (b) the Secretary of State is satisfied that the provisions of the EU TSE Regulation or of these Regulations are not being complied with. (2) The Secretary of State may amend an approval, authorisation, licence or registration granted under these Regulations if the Secretary of State considers it necessary in the light of technical or scientific developments. (3) A suspension or amendment (a) may have immediate effect if the Secretary of State considers it necessary for the protection of public or animal health; and (b) otherwise, may have effect after the expiration of at least 21 days. (4) Notification of the suspension or amendment must (a) be in writing; (b) state when the suspension or amendment comes into effect; (c) give the reasons; and (d) explain that the person who has been notified has the right to make written representations to a person appointed by the Secretary of State. (5) The appeals procedure in regulation 10 then applies. (6) If the suspension or amendment does not have immediate effect and representations are made under regulation 10, it must not have effect until the final determination of the appeal by the Secretary of State unless the Secretary of State considers that it is necessary for the protection of public or animal health for the amendment or suspension to have effect before then. Revocations of approvals, authorisations, licences or registrations 9. (1) The Secretary of State may revoke an approval, authorisation, licence or registration granted under these Regulations if the Secretary of State is satisfied that the premises will not be operated in accordance with the EU TSE Regulation or these Regulations and if (a) it is currently suspended and the period for appeal under regulation 10 has expired or the suspension has been upheld following such appeal; (b) it has been previously suspended and there is further non-compliance with the EU TSE Regulation or these Regulations; or (c) the Secretary of State is satisfied that the occupier no longer uses the premises for the purpose for which it was granted. (2) Notification of the revocation must (a) be in writing; (b) state when the revocation comes into effect; (c) give the reasons; and (d) explain that the person who has been notified has the right to make written representations to a person appointed by the Secretary of State. 7

8 (3) If the Secretary of State revokes under paragraph (1)(b) or (1)(c) the appeals procedure in regulation 10 applies, but the revocation remains in force during that appeals procedure. Appeals 10. (1) Where this regulation applies, a person may make written representations to a person appointed for the purpose by the Secretary of State concerning any decision of the Secretary of State within 21 days of notification of the decision to that person. (2) The Secretary of State may also make written submissions to the appointed person concerning the decision. (3) The appointed person must then report in writing to the Secretary of State. (4) The Secretary of State must give to the appellant written notification of the Secretary of State s final determination and the reasons for it. Valuations 11. (1) This regulation applies when a valuation is necessary under these Regulations. (2) The owner and the Secretary of State may agree on a valuation. (3) If the owner and the Secretary of State cannot agree on a valuation, they may jointly nominate a valuer to carry out a valuation. (4) If the owner and the Secretary of State cannot agree on who the valuer should be, the President of the Royal Institution of Chartered Surveyors may nominate the valuer, and both the owner and the Secretary of State must accept that nomination. (5) The valuer must carry out the valuation and submit it and any other relevant information and documentation to the Secretary of State, and provide a copy to the owner. (6) Both the owner and a representative of the Secretary of State have the right to be present at a valuation. (7) The valuation is binding on both the owner and the Secretary of State. (8) In this regulation owner means the owner of the animal or product in question. Appointment of inspectors 12. (1) Except as specified in paragraph (2), the Secretary of State and the local authority may appoint inspectors for the purposes of enforcing these Regulations. (2) The Food Standards Agency may appoint inspectors for the purposes of enforcing Schedule 7 and paragraphs 1, 3 and 4 of Schedule 8 in relation to a slaughterhouse or cutting plant. (3) The appointment of an inspector (whether under paragraph (1) or (2)) may be limited to powers and duties specified in the appointment. Powers of entry 13. (1) Inspectors have a right to enter any premises for the purpose of ensuring that the EU TSE Regulation or these Regulations are being complied with. (2) They must, if so required, produce some duly authenticated document showing their authority before exercising their right under paragraph (1). (3) They may exercise the right under paragraph (1) at all reasonable hours. (4) They may take with them (a) such other persons as they consider necessary; and (b) any representative of the European Commission acting for the purpose of the enforcement of an EU obligation. 8

9 (5) If inspectors enter any unoccupied premises or (where the premises are occupied) the occupier of the premises is temporarily absent they must leave those premises (so far as reasonably practicable) as effectively secured against unauthorised entry as the inspectors found them. (6) If a justice of the peace, on sworn information in writing, is satisfied that there are reasonable grounds for entry into any premises for the purposes of the enforcement of these Regulations, and (a) admission has been refused, or a refusal is expected, and (in either case) notice to apply for a warrant has been given to the occupier; (b) asking for admission, or the giving of such a notice, would defeat the object of the entry; (c) the case is one of urgency; or (d) the premises are unoccupied or the occupier is temporarily absent, the justice may by a signed warrant authorise inspectors to enter the premises, if need be by reasonable force. (7) A warrant under this regulation is valid for one month. Powers of inspectors 14. (1) Inspectors may (a) seize any (i) animal; (ii) body of an animal, and any parts of the body (including the blood and the hide) and any semen, embryo or ovum; (iii) animal protein or feedingstuffs that may contain animal protein; or (iv) milk or milk product, and dispose of them as necessary; (b) carry out any inquiries, investigations, examinations and tests; (c) collect, pen and inspect any animal and for this purpose may require the keeper of any such animal to arrange for the collection and penning of the animal; (d) inspect any body of an animal and any parts of the body (including the blood and the hide) and any semen, embryo or ovum; (e) inspect any part of the premises, any equipment, facility, operation or procedure; (f) take any samples; (g) have access to, and inspect and copy any records (in whatever form they are held) in order to determine if these Regulations are being complied with, including records kept under the EU TSE Regulation and these Regulations, or remove such records to enable them to be copied; (h) have access to, inspect and check the operation of, any computer and any associated apparatus or material that is or has been in use in connection with any record; and for this purpose may require any person having charge of, or otherwise concerned with the operation of, the computer, apparatus or material to afford them such assistance as the inspector may reasonably require (including providing them with any necessary passwords) and, where a record is kept by means of a computer, may require the records to be produced in a form in which they may be taken away; (i) mark anything (including an animal) whether electronically or otherwise, for identification purposes; and (j) lock or seal any container or store. (2) Any person who defaces, obliterates, or removes any mark or seal, or removes any lock, applied under paragraph (1) is guilty of an offence. (3) Inspectors are not personally liable for anything they do (a) in the execution or purported execution of these Regulations; and 9

10 (b) within the scope of their employment, if they acted in the honest belief that their duty under these Regulations required or entitled them to do it; but this does not affect any liability of their employer. Notices 15. (1) If it is necessary for any reason connected with the enforcement of the EU TSE Regulation or these Regulations inspectors may serve a notice on (a) the owner or keeper of any animal; (b) the person in possession of the body or any part of the body of an animal (including the blood and the hide) or any semen, embryo or ovum; (c) the person in possession, or supplier, of any animal protein or feedingstuffs that may contain animal protein; or (d) the owner, or person in possession, of any milk or milk products. (2) The notice must be in writing. (3) The notice may (a) prohibit or require the movement of any animal onto or from the premises specified in the notice; (b) prohibit the movement of any milk or milk products from the premises specified in the notice; (c) specify those parts of premises to which an animal may or may not be allowed access; (d) require the killing or slaughter of any animal; (e) prohibit or require the movement onto or from premises specified in the notice of the body or any part of the body (including the blood and the hide) of any animal, any animal protein or feedingstuffs that may contain animal protein, and any animal semen, embryo or ovum; (f) require the disposal of the body or any part of the body (including the blood and the hide) of any animal (whether or not it is one that was required to be detained), and any semen, embryo, ovum, milk or milk product as may be specified in the notice; (g) require the disposal of any animal protein or feedingstuffs that may contain animal protein or specify how they are to be used; or (h) require the recall of any animal protein or feedingstuffs that may contain animal protein. (4) If inspectors suspect that any premises, vehicle or container to which the EU TSE Regulation or these Regulations apply constitute, or constitutes, a risk to animal or public health, they may serve a notice on the occupier or person in charge of the premises, vehicle or container requiring that person to cleanse and disinfect all or any part of the premises, vehicle or container and any associated equipment. (5) A notice may specify how it must be complied with, and specify time limits. (6) A notice must be complied with at the expense of the person on whom it is served, and if it is not complied with inspectors may arrange to have it complied with at that person s expense. (7) Failure to comply with a notice is an offence. Notices restricting movement 16. (1) If a notice is served restricting movements of any animal or product, inspectors may subsequently permit movement under the authority of a licence. (2) The person transporting the animal or product under the authority of a licence must carry the licence with them during any movement, and produce it on demand to an inspector, and failure to do so is an offence. 10

11 Obstruction 17. A person is guilty of an offence if that person (a) intentionally obstructs an inspector acting under these Regulations; (b) without reasonable cause, fails to give to an inspector acting under these Regulations any assistance or information or to provide any facilities that the inspector may reasonably require that person to give or provide for the performance of the inspector s functions under these Regulations; (c) gives false or misleading information to an inspector acting under these Regulations; or (d) fails to produce a record when required to do so by an inspector acting under these Regulations. Penalties 18. A person guilty of an offence under these Regulations is liable (a) on summary conviction, to a fine not exceeding the statutory maximum or to imprisonment for a term of three months or both; or (b) on conviction on indictment, to a fine or to imprisonment for a term not exceeding two years or both. Corporate offences 19. (1) If an offence under these Regulations committed by a body corporate is shown (a) to have been committed with the consent or connivance of an officer; or (b) to be attributable to any neglect on their part, the officer as well as the body corporate is guilty of the offence and liable to be proceeded against and punished accordingly. (2) If the affairs of a body corporate are managed by its members, paragraph (1) applies in relation to the acts and defaults of a member in connection with their functions of management as if they were a director of the body. (3) If an offence under these Regulations committed by a partnership is shown (a) to have been committed with the consent or connivance of a partner; or (b) to be attributable to any neglect on their part, the partner as well as the partnership is guilty of the offence and liable to be proceeded against and punished accordingly. (4) If any offence under these Regulations committed by an unincorporated association, other than a partnership, is shown (a) to have been committed with the consent or connivance of an officer of the association or a member of its governing body; or (b) to be attributable to any neglect on the part of such an officer or member, that officer or member as well as the association is guilty of the offence and liable to be proceeded against and punished accordingly. (5) In this regulation (a) officer, in relation to a body corporate or unincorporated association, means a director, member of the committee of management, chief executive, manager, secretary or other similar officer of the body, or a person purporting to act in any such capacity; and (b) partner includes a person purporting to act as a partner. Enforcement 20. (1) The Secretary of State enforces Schedule 2 in slaughterhouses and cutting plants. 11

12 (2) The Food Standards Agency enforces Schedule 7 and paragraphs 1, 3 and 4 of Schedule 8 in slaughterhouses and cutting plants. (3) Otherwise these Regulations are enforced by the local authority. (4) The Secretary of State may direct, in relation to cases of a particular description or any particular case, that an enforcement duty imposed on the local authority under this regulation must be discharged by the Secretary of State and not by the local authority. Amendment of the Animal By-Products (Identification) Regulations (1) The Animal By-Products (Identification) Regulations 1995(a) are amended as follows. (2) For paragraph (3) of regulation 3 (meaning of animal by-product ) substitute (3) In these Regulations the definition of animal by-product includes (a) any product that, under paragraph 1 of Schedule 8 to the Transmissible Spongiform Encephalopathies (England) Regulations 2010, it is an offence for any person to place on the market or export (or offer to export) to third countries; and (b) where (i) a bovine animal has been slaughtered for human consumption other than in accordance with a required method of operation approved pursuant to paragraph 12(3) of Schedule 2 to the Transmissible Spongiform Encephalopathies (England) Regulations 2010, and (ii) the disposal of its body, or a part of its body, has in consequence been required under regulation 15(1), (2) and (3)(f) of those Regulations, that body or part of a body. Consequential amendment 22. In Schedule 3 of the Official Feed and Food Controls (England) Regulations 2009(b), in paragraph (a)(viii), for Transmissible Spongiform Encephalopathies (England) Regulations 2008 substitute Transmissible Spongiform Encephalopathies (England) Regulations Revocations 23. The following Regulations are revoked (a) The Transmissible Spongiform Encephalopathies (England) Regulations 2008(c); (b) The Transmissible Spongiform Encephalopathies (Fees) (England) Regulations 2008(d); and (c) The Transmissible Spongiform Encephalopathies (England) (Amendment) Regulations 2008(e). 8th March 2010 Jim Fitzpatrick Minister of State Department for Environment, Food and Rural Affairs (a) S.I. 1995/614, as last amended by S.I. 2009/1119. (b) S.I. 2009/3255. (c) S. I. 2008/1881. (d) S. I. 2008/2269. (e) S. I. 2008/

13 11th March 2010 Tony Cunningham Frank Roy Two of the Lord Commissioners of Her Majesty s Treasury SCHEDULES SCHEDULE 1 Regulation 2(3) Ambulatory References The EU instruments that must be construed as amended from time to time are (a) The EU TSE Regulation; (b) Regulation (EC) No 1774/2002; (c) Regulation (EC) No 853/2004; (d) Regulation (EC) No 882/2004; (e) Commission Decision 2007/411/EC; (f) Commission Decision 2007/453/EC; and (g) Commission Decision 2009/719/EC. SCHEDULE 2 TSE Monitoring Regulation 5(a) CONTENTS PART 1 Monitoring for TSE 1. Notification of the body of a goat for the purpose of monitoring under Article 6 of the EU TSE Regulation Delivery of the body of a bovine animal for the purpose of monitoring under Article 6 of the EU TSE Regulation Persons collecting and delivering Destruction without sampling Retention of bodies of bovine animals pending test results Remote Areas Consignment and slaughter of an over-age bovine animal Brain stem sampling of bovine animals (slaughterhouses) Brain stem sampling of bovine animals (other places of slaughter) Approval of laboratories Approved sampling sites Slaughter of bovine animals 17 13

14 13. Retention of products and disposal TSE sampling of sheep, goats and deer Compensation 18 PART 2 Contents of an RMOP 16. Animal identification and separation Brain stem sampling Correlation of sample to carcase and all other parts of the body Retention of carcases Retention of parts of the body Disposal before receipt of the result Other measures following sampling 20 PART 1 Monitoring for TSE Notification of the body of a goat for the purpose of monitoring under Article 6 of the EU TSE Regulation 1. (1) For the purpose of monitoring under Article 6 of the EU TSE Regulation, a person who has in their possession, or under their control, the body of a goat aged 18 months or over at death, must (a) notify the Secretary of State within 24 hours from the time when the animal died or was killed or the body came into their possession or under their control; and (b) where the Secretary of State directs, detain it until it has been collected by or on behalf of the Secretary of State, and failure to do so is an offence. (2) This paragraph does not apply in relation to goats slaughtered for human consumption or killed in accordance with Schedule 4. Delivery of the body of a bovine animal for the purpose of monitoring under Article 6 of the EU TSE Regulation 2. (1) For the purpose of monitoring under Article 6 of the EU TSE Regulation, a person who has in their possession or under their control the body of a bovine animal that must be tested for BSE in accordance with point 3(1) of Part I of Chapter A of Annex III to that Regulation must, unless directed otherwise by the Secretary of State, within 24 hours either (a) make arrangements with another person for that person to collect it and to deliver it to an approved sampling site within 72 hours; or (b) identify an approved sampling site that will carry out the sampling and deliver the animal to that site so as to arrive at the site within 72 hours, and failure to do so is an offence. (2) The periods of 24 and 72 hours referred to in sub-paragraph (1) run from the time when the animal died or was killed or came into the possession or under the control of the person to whom the requirements of that sub-paragraph apply. 14

15 Persons collecting and delivering 3. A person with whom arrangements are made under paragraph 2 for the delivery of a body to an approved sampling site must, unless directed otherwise by the Secretary of State, within 48 hours of the time when the body comes into their possession or under their control (a) identify an approved sampling site that will carry out the sampling; and (b) ensure it is delivered to that site, and failure to do so is an offence. Destruction without sampling 4. Any person who destroys the body of a bovine animal to which paragraph 2(1) applies before it has undergone sampling at an approved sampling site, except in accordance with a direction of the Secretary of State, commits an offence. Retention of bodies of bovine animals pending test results 5. An approved sampling site to which the body of a bovine animal has been sent for sampling in accordance with this Part must retain it in accordance with point 6(3) of Chapter A of Annex III to the EU TSE Regulation, and failure to do so is an offence. Remote Areas 6. (1) The requirements of paragraphs 1(1) and 2 do not apply in relation to an animal that has died or been killed in the Isles of Scilly, the Isle of Wight or Lundy Island. (2) The exemption in sub-paragraph (1) continues to apply even if the body of the animal has been removed from the Isles of Scilly, the Isle of Wight or Lundy Island, as the case may be. Consignment and slaughter of an over-age bovine animal 7. (1) If a bovine animal was born or reared in the United Kingdom before 1st August 1996, it is an offence (a) to consign it to a slaughterhouse for human consumption (whether the animal is alive or dead); or (b) to slaughter it for human consumption. (2) For the purposes of sub-paragraph (1), a bovine animal is deemed to have been born or reared in the United Kingdom before 1st August 1996 unless its cattle passport shows either that (a) it was born in the United Kingdom on or after 1st August 1996; or (b) it first entered the United Kingdom on or after 1st August Brain stem sampling of bovine animals (slaughterhouses) 8. (1) The occupier of a slaughterhouse, in which a bovine animal covered by point 2 of Part I of Chapter A of Annex III to the EU TSE Regulation is slaughtered or (if the animal is slaughtered at a place other than a slaughterhouse) processed must (a) take a sample comprising the brain stem for testing in accordance with point 1 of Chapter C of Annex X to the EU TSE Regulation, (b) ensure that the animal from which the sample has been taken can be identified, and (c) arrange for the sample to be delivered to an approved testing laboratory, and failure to do so is an offence. (2) The Secretary of State must, by means of a notice, notify the occupier of a slaughterhouse if an animal comes into any of the categories specified in point 2(1) of Part I of Chapter A of Annex III to 15

16 the EU TSE Regulation (except in the case of a dead animal consigned to a slaughterhouse with a written declaration from a veterinary surgeon that it falls into one of those categories). (3) In accordance with point 5 of Part I of Chapter A of Annex III to the EU TSE Regulation, the Secretary of State may serve a notice on the occupier of a slaughterhouse requiring them to take a sample from any bovine animal slaughtered there and send it for testing in accordance with subparagraph (1). Brain stem sampling of bovine animals (other places of slaughter) 9. The occupier of a place (a) that, for the purposes of point 4(1)(a) of Annex V to the EU TSE Regulation, is an other place of slaughter; and (b) in which a bovine animal covered by point 2 of Part I of Chapter A of Annex III to the EU TSE Regulation is slaughtered must (i) arrange for a sample, comprising the brain stem, to be taken for testing in accordance with point 1 of Chapter C of Annex X to the EU TSE Regulation, (ii) ensure that the animal from which the sample has been taken can be identified, and (iii) arrange for the sample to be delivered to an approved testing laboratory, and failure to do so is an offence. Approval of laboratories 10. (1) The Secretary of State must approve laboratories to test samples taken under paragraph 8 if the Secretary of State is satisfied that the laboratory (a) will carry out the testing in accordance with Chapter C of Annex X to the EU TSE Regulation; (b) has adequate quality control procedures; and (c) has adequate procedures to ensure the correct identification of the samples and notification of the test results to the consigning slaughterhouse and to the Secretary of State. (2) The Secretary of State may charge the fees set out in the following table for the initial approval and ongoing quality assessment of a laboratory Fees Laboratory approvals and quality assessments Fee ( ) Initial approval 29,770 Annual proficiency testing and follow-up inspection for the first 8,834 year after approval Annual proficiency testing from the second year after approval 4,135 Single proficiency test (in the event of a failure in the annual 1,385 proficiency testing) Hourly rate of an inspector (for any additional inspections that are necessary to check for compliance with the matters set out at subparagraphs (1)(a) to (c)) (3) For the purposes of this paragraph and paragraphs 8 and 9, an approved testing laboratory means (a) a laboratory approved under this paragraph; (b) a laboratory approved under corresponding legislation elsewhere in the United Kingdom; (c) an EU National Reference Laboratory; or (d) a diagnostic laboratory approved by a member State in accordance with Annex X to the EU TSE Regulation. 16

17 Approved sampling sites 11. (1) The Secretary of State must on application approve a sampling site to sample animals to which paragraph 2 applies if satisfied that the sampling site has adequate control procedures to carry out the sampling. (2) An approved sampling site in this Part means a sampling site approved under this paragraph or a sampling site in another part of the United Kingdom approved by the competent authority in that part of the United Kingdom to carry out sampling for the same purpose. Slaughter of bovine animals 12. (1) It is an offence for the occupier to use a slaughterhouse to slaughter for human consumption a bovine animal that, in accordance with point 2 of Part I of Chapter A of Annex III to the EU TSE Regulation, requires BSE testing at slaughter, unless the Secretary of State has approved the Required Method of Operation ( RMOP ) for that slaughterhouse and that occupier. (2) The RMOP must, as a minimum, describe (a) the procedures that will be followed to comply with Part 1 of this Schedule; and (b) all the systems and procedures specified in Part 2 of this Schedule. (3) The Secretary of State must approve the RMOP if satisfied that all the requirements of the EU TSE Regulation and these Regulations will be complied with, and the occupier must demonstrate this by means of an assessment of two days duration during which animals are slaughtered (using bovine animals that are not required, under point 2 of Part 1 of Chapter A of Annex III to the EU TSE Regulation, to be tested for BSE). (4) If a bovine animal referred to in paragraph (1) is slaughtered for human consumption other than in accordance with the RMOP, the occupier of the slaughterhouse is guilty of an offence. Retention of products and disposal 13. (1) In relation to any sampled bovine animal, the occupier of a slaughterhouse, other place of slaughter (for the purposes of point 4(1)(a) of Annex V to the EU TSE Regulation), hide market or tannery must, for the purposes of point 6(3) of Part I of Chapter A of Annex III to the EU TSE Regulation and pending receipt of the test result, either (a) retain all carcases and all parts of the body (including the blood and the hide) that will have to be disposed of in the event of a positive result; or (b) dispose of them in accordance with sub-paragraph (2). (2) For the purposes of points 6(4) and 6(5) of that Part, if a positive result is received for a sampled animal, the occupier must immediately dispose of (a) the carcase and all parts of the body of that animal (including the blood and the hide); and (b) unless a derogation has been granted under sub-paragraph (5), the carcase and all parts of the body (including the blood and the hide) of the animal immediately preceding that animal on the slaughter line and the two animals immediately following it, in accordance with point 6(4) of that Part. (3) If no sample has been sent to, or no sample has been received by, an approved testing laboratory for testing in accordance with paragraph 8 and 9 of this Schedule, or if an insufficient test result is received, in respect of an animal required to be tested under this Schedule, the occupier must immediately dispose of (a) the carcase and all parts of the body (including the blood and the hide) of that animal; and (b) unless a derogation has been granted under sub-paragraph (5), the carcase and all parts of the body (including the blood but not the hide) of the animal immediately preceding that animal on the slaughter line and the two animals immediately following it, in accordance with point 6(4) of that Part; and for the purposes of this sub-paragraph an insufficient test result means a certification by an approved testing laboratory that the sample 17

18 sent to the laboratory was not of an adequate quality or was not of a sufficient quantity to obtain a test result. (4) If a no-test result is received, in respect of an animal required to be tested under this Schedule, the occupier must immediately dispose of the carcase and all parts of the body (including the blood and the hide) of that animal in accordance with point 6(4) of that Part; and for the purposes of this sub-paragraph a no-test result means a negative result from a sample following multiple rapid testing where such testing was certified as necessary by an approved testing laboratory. (5) The Secretary of State may grant in writing a derogation under point 6(6) of Part I of Chapter A of Annex III to the EU TSE Regulation if satisfied that the slaughterhouse operates a system that prevents contamination between carcases. (6) Any person who fails to comply with sub-paragraphs (1) to (4) is guilty of an offence. TSE sampling of sheep, goats and deer 14. (1) In relation to any sheep or goat selected for sampling, the occupier of a slaughterhouse, hide market or tannery must (a) for the purposes of point 7(3) of Part II of Chapter A of Annex III to the EU TSE Regulation, retain the carcase and all parts of the body (including the blood and the hide) pending receipt of the test result (except to the extent that point 7(3) permits direct disposal of animal by-products pending receipt of a negative rapid test result); and (b) in the event of a positive result, immediately dispose of the carcase and all parts of the body (including the blood and the hide) in accordance with point 7(4) of that Part. (2) Where (a) a sheep, goat or deer has died, or has been killed, other than for human consumption; and (b) either (i) the death or killing occurred at premises approved, or required to be approved, under the Animal By-Products Regulations 2005; or (ii) the carcase of the sheep, goat or deer has been taken to those premises, the occupier of the premises must comply with any direction given by the Secretary of State requiring the carcase to be sampled at the premises. (3) In relation to any deer selected for monitoring for TSE in accordance with Part III of Chapter A of Annex III to the EU TSE Regulations, the occupier of a slaughterhouse, hide market or tannery must (a) retain the carcase and all parts of the body (including the blood and the hide) pending receipt of the test result; and (b) in the event of a positive result, immediately dispose of the carcase and all parts of the body (including the blood and the hide) in accordance with point 7(4) of Part II of Chapter A of Annex III to the EU TSE Regulation. (4) Any person who fails to comply with sub-paragraphs (1), (2) or (3) is guilty of an offence. Compensation 15. (1) If an animal slaughtered for human consumption tests positive, the Secretary of State must pay to the occupier of the slaughterhouse or other place of slaughter compensation for the carcase and all parts of the body (including the blood and the hide) of (a) that animal; and, (b) if they are destroyed because of that positive result, the animal immediately preceding it on the slaughter line and the two animals immediately following it. (2) The compensation is the market value, and if a market value cannot be agreed the valuation must be established in accordance with the procedure laid down in regulation 11(3) to (8) (reading 18

19 the word occupier wherever owner is mentioned in those paragraphs), with the occupier paying any valuation fee arising. (3) For the purposes of sub-paragraph (2), the market value is the price that would reasonably be expected to have been obtained for the animal from a buyer in the open market at the time of the valuation, and on the assumption that the animal was not affected by a TSE. Animal identification and separation PART 2 Contents of an RMOP 16. (1) The RMOP (as specified in paragraph 12) must describe the system that (a) enables bovine animals born or reared in the United Kingdom before 1st August 1996 to be identified and ensures that they are not slaughtered for human consumption; (b) enables bovine animals that, in accordance with point 2(1) of Part I of Chapter A of Annex III to the EU TSE Regulation, require BSE testing, to be identified and ensures that they are sampled in accordance with this Schedule; and (c) enables bovine animals that, in accordance with point 2(2) of Part I of Chapter A of Annex III to the EU TSE Regulation, require BSE testing at slaughter, to be identified and ensures that they are sampled in accordance with this Schedule. (2) The requirements of sub-paragraph (1)(b) and (c) apply only in relation to bovine animals born or reared in the United Kingdom on or after 1st August (3) The RMOP must also describe the system that ensures that animals to which sub-paragraphs (1)(b) and (c) applies are (a) batched together before slaughter separately from those not referred to in sub-paragraphs (1)(b) and (c); and (b) slaughtered in batches separately from those not referred to in sub-paragraph (1)(b) and (c). (4) For the purposes of this paragraph, a bovine animal is deemed to have been born or reared in the United Kingdom before 1st August 1996 unless its cattle passport shows either that (a) it was born in the United Kingdom on or after 1st August 1996; or (b) it first entered the United Kingdom on or after 1st August Brain stem sampling 17. (1) The RMOP must show that there are (a) sufficient staff trained and competent in the taking, labelling, packaging and dispatch of brain stem samples; (b) hygienic facilities for sampling; and (c) sampling procedures that do not jeopardise the hygienic production of meat intended for human consumption. (2) It must describe how health and safety guidelines designed to minimise the risk of exposure of staff to a TSE during brain stem sampling and packaging will be complied with. Correlation of sample to carcase and all other parts of the body 18. The RMOP must describe the system linking the brain stem sample of each bovine animal to which paragraph 16(1)(b) and (c) of this Schedule applies, to the carcase of that animal and all parts of the body of that animal (including the blood and the hide). 19